(266 days)
No
The device description explicitly states that the ECG signal is "not intended for automated analysis" and is "solely intended for manual interpretation." There is no mention of AI or ML in the document.
No.
The device is an ECG recorder, which collects cardiac rhythm data for diagnostic purposes (manual interpretation by physicians) and not for treating a disease or condition. While it aids in diagnosis, it does not provide therapy.
Yes
The device records ECG data, which physicians use for diagnosis. The "Device Description" states, "Physicians could later look back at the data and use it in the diagnosis."
No
The device description explicitly mentions "EZYPRO ECG Recorder (Model: UG02)" which is a physical, wearable device that records ECG data. It also mentions hardware components like a blue button and a USB connection. While it includes software components (EZY iSee APP and UG02 setting tool), the core medical device is the hardware recorder.
Based on the provided information, the EZYPRO ECG Recorder (Model: UG02) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The EZYPRO ECG Recorder records electrical signals from the surface of the skin (ECG data), which is a physiological measurement, not a specimen derived from the body.
- The intended use describes recording cardiac rhythm. This is a physiological monitoring function, not a diagnostic test performed on a biological sample.
- The device description focuses on recording and transmitting ECG data. There is no mention of analyzing biological samples like blood, urine, or tissue.
The EZYPRO ECG Recorder is a medical device used for physiological monitoring and recording, specifically for cardiac rhythm. It is intended for use by medical professionals for manual interpretation of the recorded data to aid in diagnosis, but it does not perform diagnostic tests on biological specimens, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.
The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.
Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the diagnosis.
EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left Sternum
Indicated Patient Age Range
patients who are older than 21 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety and performance tests were conducted on the subject device, EZYPRO ECG Recorder (Model: UG02).
- . Reliability Test
- Reliability Test (ME)
- Reliability Evaluation (500 cycles reusable) -
- Shelf Life Test .
- . Biocompatibility
- Biological evaluation of medical device ।
- In Vitro Cytotoxicity Test (Agar Diffusion)
- Intracutaneous Irritation Study in Rabbits
- Skin Sensitization Study in Guinea Pigs (Maximization Test) ।
- . Software
- Recorder Firmware Validation ।
- EZY iSee Software Validation
- UG02 Setting Tool Software Validation
- Cybersecurity Cybersecurity Management
- Electromagnetic compatibility and electrical safety test ●
- IEC 60601-1 Test
- EMC Test
- Radio Spectrum Test ।
- SAR Evaluation ।
- Safety Requirements for Portable Sealed Secondary Cells ।
- Lithium Polymer Battery Safety Test
- IEC 60601-1-11 Test
- Energy Reduction Test ।
- Performance test .
- IEC 60601-2-47 Test
- Product Function Test (EE)
- Disposable ECG electrodes Test
- QRS and Heart Rate Accuracy
- HFE/UE .
- . MR Unsafe Evaluation
- RF Wireless Evaluation
All the test results demonstrate EZYPRO ECG Recorder (Model: UG02) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 23, 2022
Sigknow Biomedical Co.,Ltd. Hsiao-Fan Liu Regulatory Affairs 6F., No. 760, Sec. 4, Bade Rd., Songshan Dist, Taipei City, 105412 Taiwan
Re: K213233
Trade/Device Name: EZYPRO ECG Recorder (Model: UG02) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: May 16, 2022 Received: May 26, 2022
Dear Hsiao-Fan Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K213233
Device Name EZYPRO ECG Recorder (Model: UG02)
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac thythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG Recorder (Model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| 5.1 | Type of Submission | Traditional |
|---|---|---|
| 5.2 | Date of Summary | 06/17/2022 |
| 5.3 | Submitter | Sigknow Biomedical Co., Ltd. |
| Address: 6F., No.760, Sec. 4, Bade Rd., Songshan Dist., | ||
| Taipei City 105, Taiwan (R.O.C.) | ||
| Phone: +886-2-2761-2577 | ||
| Contact: Hsiao-Fan Liu | ||
| vera.liu@sigknow.com.tw |
5.4 Identification of the Device
| Proprietary/Trade Name: | EZYPRO ECG Recorder (Model:
UG02) |
|-------------------------|------------------------------------------------------------------|
| Model Number: | UG02 |
| Regulation Description: | Radiofrequency physiological signal
transmitter and receiver. |
| Review Panel: | Cardiovascular |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |
રત્ત Identification of the Predicate Device
| Predicate Device Name: | Rooti Rx System ECG Event
Recorder, Rooti Link APP Software |
|------------------------|----------------------------------------------------------------|
| Model Number: | — |
| 510(k) Number: | K163694 |
| Manufacturer: | Rooti Labs Ltd. |
| Regulation Number: | 870.2910 |
| Product Code: | DRG |
| Device Class: | II |
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5.6 Identification of the Reference Device
| Reference Device Name: | ZIO® Patch |
|---|---|
| Model Number: | — |
| 510(k) Number: | K121319 |
| Manufacturer: | iRhythm Technologies, Inc. |
| Regulation Number: | 870.2800 |
| Product Code: | DSH |
| Device Class: | II |
Intended Use/Indications for Use of the Device 5.7
EZYPRO ECG Recorder (Model: UG02) is a prescription-only, single-patient-use, continuously recording single-lead cardiac rhythm recorder that can be worn up to 14 days each time through recharge. It is indicated for use on patients who are older than 21 years old. At the end of the recording, the recorded ECG data can be transferred in an available file on PC via the USB connection.
During wearing, EZYPRO ECG recorder (model: UG02) can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals. EZY iSee does not contain diagnostic interpretation.
UG02 setting tool is a program executed on the Windows OS platform and to provide an interface for setting up operational parameters of EZYPRO ECG Recorder (Model: UG02) and downloading the recorded ECG data.
5.8 Device Description
EZYPRO ECG Recorder (Model: UG02) can record cardiac rhythm up to 14 days. Wearing duration is adjustable based on different needs of the physicians.
The recorder is lightweight, wire free, and easy to carry around; Will not interfere patient's daily routine or any activities.
Patient's symptomatic episodes can be marked by proactive pressing the blue button on the recorder; Physicians could later look back at the data and use it in the
5
diagnosis.
EZYPRO ECG Recorder is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis.
5.9 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, EZYPRO ECG Recorder (Model: UG02).
- . Reliability Test
- Reliability Test (ME)
- Reliability Evaluation (500 cycles reusable) -
- Shelf Life Test .
- . Biocompatibility
- Biological evaluation of medical device ।
- In Vitro Cytotoxicity Test (Agar Diffusion)
- Intracutaneous Irritation Study in Rabbits
- Skin Sensitization Study in Guinea Pigs (Maximization Test) ।
- . Software
- Recorder Firmware Validation ।
- EZY iSee Software Validation
- UG02 Setting Tool Software Validation
- Cybersecurity Cybersecurity Management
- Electromagnetic compatibility and electrical safety test ●
- IEC 60601-1 Test
- EMC Test
- Radio Spectrum Test ।
- SAR Evaluation ।
- Safety Requirements for Portable Sealed Secondary Cells ।
- Lithium Polymer Battery Safety Test
- IEC 60601-1-11 Test
- Energy Reduction Test ।
- Performance test .
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- IEC 60601-2-47 Test
- Product Function Test (EE)
- Disposable ECG electrodes Test
- QRS and Heart Rate Accuracy
- HFE/UE .
- . MR Unsafe Evaluation
- RF Wireless Evaluation
All the test results demonstrate EZYPRO ECG Recorder (Model: UG02) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
5.10 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
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5.11 Substantial Equivalence Determination
EZYPRO ECG Recorder (Model: UG02) submitted in this 510(k) file is substantially equivalent in intended use, safety and performance to the cleared Rooti Rx System (K163694). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K213233 | K163694 | N/A |
| Proprietary
Name | EZYPRO ECG Recorder (Model: UG02) | Rooti Rx System ECG Event
Recorder, Rooti Link APP Software | N/A |
| Manufacturer | Sigknow Biomedical Co., Ltd. | Rooti Labs Limited | N/A |
| Regulation
Number | 21 CFR 870.2910 | 21 CFR 870.2910 | Same |
| Classification | Class II | Class II | Same |
| Product Code | DRG | DRG | Same |
| Intended Use | EZYPRO ECG Recorder (Model: UG02)
is a prescription-only, single-patient-use,
continuously recording single-lead cardiac
rhythm recorder that can be worn up to 14
days each time through recharge. It is | The intended use of the Rooti Rx
System is to allow a patient at home
or in the workplace to record
single-lead electrocardiography
(ECG) data for post-analysis by | Similar
The subject device is to record
single-lead cardiac rhythm from
patients who are older than 21
years old; its medical indication is |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | indicated for use on patients who are older
than 21 years old. At the end of the
recording, the recorded ECG data can be
transferred in an available file on PC via
the USB connection.
During wearing, EZYPRO ECG recorder
(model: UG02) can digitally transmit ECG
data to the mobile device with the APP
(EZY iSee) embedded through Bluetooth
technology, supporting spot checks on
signals. EZY iSee does not contain
diagnostic interpretation.
UG02 setting tool is a program executed
on the Windows OS platform and to
provide an interface for setting up
operational parameters of EZYPRO ECG
Recorder (Model: UG02) and downloading
the recorded ECG data. | medical professionals. The Rooti Rx
device stores the ECG data, and the
recorded data is transmitted to a
medical professional's iOS device
via Wi-Fi at a later time.
The device is not intended to be used
on critical care patients.
The Rooti Rx System is indicated for
use on general care patients and on
patients who are 21 years of age or
older. | same as the predicate device.
The recorded data could be
transmitted wireless to a medical
professional's equipment.
The subject device has additional
component, UG02 setting tool that
can set up the operational
parameters and download the data. |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| Data Storage
Capacity | 14 days | 7 days | Different
The subject device has more
capacity. And the software
validation and performance tests
could demonstrate that it would not
affect the safety and effectiveness. |
| Method of
Application | Designed adhesive electrode | Off the shelf adhesive electrode | Different
The subject device has exclusive
electrode, and the function of
exclusive electrode has been tested.
It could demonstrate the substantial
equivalence of devices. |
| ECG channel | Channel 1, Single lead | Channel 1, Single lead | Same |
| Electrode
Position | Left Sternum, inclined
(Self-defined position called
"ECG Channel A") | Left Sternum, horizontal | Different
A reference device (ZIO Patch,
K121319) which are applied to the
similar position as the subject
device was used to support the |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | | | technological characteristic. The
relevant evaluation and tests
could demonstrate the subject
device is substantially equivalent
to the predicate. |
| ECG resolution | 18 bits, ±5mV | 24 bits, 6mVp-v, offset ±300mV | Different
The subject device has lower ECG
resolution.
Performance tests shown that it
meets the requirements and the
device is substantially equivalent
to the predicate. |
| ECG sampling
rate (Hz) | 256 | 500 | Different
Both are more than double the
highest useful frequency
component (40Hz).
Performance tests shown that it
meets the requirements and the |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | | | device is substantially equivalent to
the predicate. |
| Water resistant | Yes | Yes | Same |
| Data
transmission | Bluetooth | Wifi | Different
Although they are different in data
transmission, it doesn't affect the
device function.
Software validation demonstrated
that it meets the requirements. |
| Power source | 360 mAh lithium battery
(Rechargeable battery) | 240 mAh lithium battery
(Rechargeable battery) | Similar
The subject device has more
quantity of electricity.
The relevant electric safety tests
shown that it meets the
requirements. |
| Weight (g) | 20 | 14 | Similar
Although the subject device is
heavier due to the battery, it |
| Item | Subject device | Predicate device | Substantial
equivalence
determination |
| | | | doesn't affect the device function. |
| Dimensions
(mm) | 47 (L) x 32 (W) x 12 (H) mm | 62 x 22.5 x 8.45 mm | Similar
Although the subject device is
larger due to the battery, it doesn't
affect the device function. |
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10
11
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5.12 Similarity and Difference
In terms of the intended use, the subject device and the predicate device are much similar.
The subject device can be worn up to 14 days to record ECG data. During wearing, it can digitally transmit ECG data to the mobile device with the APP (EZY iSee) embedded through Bluetooth technology, supporting spot checks on signals just for making sure the device are working normally. At the end of the recording, the recorded ECG data can be downloaded from recorder for post-analysis by medical professionals.
The predicate device can be worn up to 7 days to record ECG data. During wearing, the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time for post-analysis.
Both of them are used on general care patients and on patients who are 21 years of age or older. They are both used at home or in the workplace, and the recorded data is finally received to medical professionals.
Therefore, the intended use and the indication for use for the subject device are substantially equivalent to the predicate device.
In the terms of electrode position, the subject device adopts a specific position named "ECG Channel A", which is different from the predicate. Therefore, a reference device (ZIO Patch, K121319) applied to a similar position was added to support the technological characteristic.
In terms of the specification, because of the larger battery, the subject device has bigger data storage capacity, power source, weight and dimension so that it can record ECG data up to 14 days.
On the other hand, although there are some differences on data transmission technology, ECG resolution, and ECG sampling rate, they do not affect the safety and performance of the subject device based on the provided test reports.
In terms of the ECG patch, the subject device has exclusive electrode, and the
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function of exclusive electrode has been tested to demonstrate substantial equivalence
5.13 Conclusion
In conclusion, according to the substantial equivalence discussion, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device in all respects. The intended use for the EZYPRO ECG Recorder (Model: UG02) are substantially equivalent to the predicate device. The performance testing results demonstrate that any differences in the technological characteristics between the devices are incidental and not significant which do not raise any new issues of safety or efficacy as compared to the predicate. Therefore, the EZYPRO ECG Recorder (Model: UG02) is substantially equivalent to the predicate device.